BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC CONTROL SYSTEMS INC.

    MDR report key: 346808 · Received August 7, 2001

    Report

    Report Number
    MW1022607
    Event Type
    Malfunction
    Date Received
    August 7, 2001
    Date of Event
    July 31, 2001
    Report Date
    August 7, 2001
    Manufacturer
    CCS
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAS A CARDIAC CONTROL SYSTEMS INC. CARDIAC PACEMAKER IMPLANTED ON 5/96 CARDIAC CONTROL SYSTEMS HAS GONE OUT OF BUSINESS AND THERE IS NOT ANY TECHNICAL SUPPORT OR EQUIPMENT AVAILABLE. THE 1-800-CCS-PACE PHONE # IS NOT IN SERVICE. THIS PACEMAKER WAS FOUND TO BE @ "ELECTIVE REPLACEMENT INDICATOR" DURING A TRANS-TELEPHONIC MONITORING TEST. AVAILABILITY OF CARDIAC CONTROL SYSTEMS PROGRAMMER COULD HAVE REVEALED THE EXACT BATTERY VOLTAGE REMAINING AND MADE THE REPLACEMENT DECISION MORE ACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35581 CARDIAC CONTROL SYSTEMS INC. CARDIAC PACEMAKER DXY CCS 533 *

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Other